Search Results

The LYMA Laser PRO is an Over-the-Counter (OTC) light based device intended for the use in treating face wrinkles.

The LYMA Laser PRO is a compact, handheld laser device intended to provide low-level laser light therapy (LLLT) for the treatment of wrinkles. The LYMA Laser PRO system is composed of a handheld casing enclosing three low-level, 808nm laser diodes, and three red light-emitting diodes (LED). The device also includes one white LED that inform the user about device status during operation, and optical lenses that diffuse the laser light across a larger treatment window. The LYMA Laser PRO includes a rechargeable battery and is provided with a power cable.

The provided text is an FDA 510(k) clearance letter and summary for the LYMA Laser PRO. It details the device's indications for use, comparison to predicate devices, and a summary of non-clinical testing performed.

Crucially, the document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence."

Therefore, based on the provided text, there is no clinical study performed to prove the device meets acceptance criteria for efficacy in treating wrinkles. The device was deemed substantially equivalent to predicate devices based on non-clinical testing (biocompatibility, electrical/mechanical/thermal safety, laser safety, and electromagnetic compatibility).

As such, I cannot provide the requested information regarding acceptance criteria, reported device performance from a clinical study, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical efficacy study, because no such study was conducted or reported in this document.

The primary reason for clearance was substantial equivalence to existing devices that treat wrinkles, not a de novo demonstration of efficacy through a clinical trial.

Ask a specific question about this device